주요업무
💭 About the Team & Position
• We are seeking a Senior Human Factors & Usability Specialist to lead the planning, execution, and documentation of usability and human factors engineering (HFE) activities across our portfolio of AI-powered cancer screening software and platforms.
• This role plays a critical part in ensuring our products are safe, intuitive, and regulatory-compliant, especially within the context of IEC 62366, FDA guidance, and other international usability standards for medical devices. The ideal candidate brings a strong background in user-centered design research, risk-informed usability testing, and cross-functional collaboration in regulated healthcare product development.
• You will work closely with product managers, designers, engineers, clinicians, and regulatory teams to embed usability and human factors principles into our development lifecycle - helping us deliver clinically meaningful, easy-to-use products for healthcare providers around the world.
🚩 Roles & Responsibilities
1. Human Factors Strategy & Planning
• Define and lead human factors engineering strategy across multiple regulated software products (SaMD).
• Contribute to usability planning at concept, development, and validation stages.
• Ensure activities align with IEC 62366, FDA HFE guidance, and international regulations.
2. Usability Testing & Research Execution
• Design and conduct formative and summative usability evaluations with clinical users (e.g., radiologists, technologists).
• Develop research protocols, moderator guides, and participant recruitment strategies.
• Analyze qualitative/quantitative data to identify usability risks and design improvement opportunities.
3. Documentation & Risk Management
• Own usability engineering files and documentation for regulatory submissions, audits, and design history files.
• Collaborate with risk management to integrate usability-related hazards into FMEAs and risk controls.
• Create traceability between user needs, design inputs, and usability outcomes.
4. Cross-Functional Enablement
• Partner with product design and development teams to ensure usability is embedded in every design iteration.
• Work closely with RA/QA teams to align testing strategies with submission timelines.
• Serve as internal subject matter expert on usability engineering and standards